US2024269173A1PendingUtilityA1

Biological Fluid Concentration Devices and Methods of Use

Assignee: ARTHREX INCPriority: Feb 13, 2023Filed: Feb 12, 2024Published: Aug 15, 2024
Est. expiryFeb 13, 2043(~16.5 yrs left)· nominal 20-yr term from priority
A61K 35/19A61K 9/0024A61K 35/16A61M 1/3693
65
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Claims

Abstract

Provided herein are devices for concentrating biological fluids such as serum or plasma, methods of using biological fluid concentrators, and methods of treatment of soft tissue damage and injuries.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A biological fluid concentration device  300  comprising:
 (i) an upper body  310  comprising a distal end  312  and a proximal end  311 , a chamber  313 , and a valve  314 ; 
 (ii) a lower body  330  comprising a distal end  332 , a proximal end  331 , a chamber  338  containing a concentration material  336 ; a valve  333  at the distal end  332  of the lower body  330 ; and a port  334 ; and 
 (iii) a filter  319 , grate  320 , or combination of a filter and a grate located between the upper body and the lower body; configured such that the biological fluid can flow from the lower chamber, through the filter and/or grate, and into the upper chamber. 
 
     
     
         2 . The biological fluid concentration device of  claim 1 , wherein the lower body  330  further comprises threads  337  at the distal end  332  of the lower body. 
     
     
         3 . The biological fluid concentration device of  claim 1 , wherein the lower body  330  further contains one or more agitator particles  335 . 
     
     
         4 . The biological fluid concentration device of  claim 1 , wherein the concentration material  336  is polyacrylamide beads. 
     
     
         5 . The biological fluid concentration device of  claim 1 , wherein the lower body, upper body, and filter, grate, or combination of filter and grate can be screwed together or press fit together. 
     
     
         6 . The biological fluid concentration device of  claim 1 , wherein the filter, grate, or combination of filter and grate has pores sized to retain the concentration material within the chamber of the lower device. 
     
     
         7 . A method of concentrating a biological fluid comprising:
 inserting biological fluid into the chamber of the lower body of the biological fluid concentration device of  claim 1 ;   shaking the device;   inverting the device so that the lower body is orientated upwards and placing the device into a centrifuge;   centrifuging the device such that concentrated biological fluid is collected in the upper body;   withdrawing the concentrated biological fluid from the upper body.   
     
     
         8 . The method of  claim 7 , wherein the lower body of the biological fluid concentration device comprises threads at the distal end of the lower body. 
     
     
         9 . The method of  claim 7 , wherein the biological fluid is plasma, whole blood, serum, platelet rich plasma, buffy coat, platelet poor plasma, bone marrow mononuclear cells (BMMC), or stromal vascular fraction (SVF) from adipose tissue. 
     
     
         10 . The method of  claim 8 , wherein the biological fluid is inserted into the chamber of the lower body of the device by screwing a device for preparation of platelet rich plasma (PRP) onto the threads at the distal end of the lower body and directly inserting the PRP into the chamber of the lower body through the valve  333 . 
     
     
         11 . The method of  claim 10 , further comprising attaching a fluid extraction device to the valve  314  of the upper body. 
     
     
         12 . The method of  claim 11 , further comprising injecting the concentrated biologic fluid of the chamber of the upper body into a ligament, tendon, bone, cartilage, or joint space of a patient. 
     
     
         13 . A method of treatment of soft tissue damage or injury comprising isolating plasma from a patient with soft tissue damage or injury and placing the plasma in the chamber of the lower body of the device of  claim 1 ,
 shaking the device;   inverting the device so that the lower body is orientated upwards and placing the device into a centrifuge   centrifuging the device such that concentrated plasma is collected in the upper body;   withdrawing the concentrated plasma from the upper body; and   contacting the soft tissue damage or injury with the concentrated plasma.   
     
     
         14 . The method of  claim 13 , wherein the soft tissue damage or injury is damage or injury to a ligament, tendon, muscle, or joint. 
     
     
         15 . The method of  claim 14 , wherein the tendon is a patellar tendon, anterior tibialis tendon, Achilles tendon, Hamstring tendon, semitendinosus tendon, gracilis tendon, abductor tendon, adductor tendon, supraspinatus tendon, infraspinatus tendon, subscapularis tendon, teres minor tendon, flexor tendon, rectus femoris tendon, tibialis posterior tendon, or quadriceps femoris tendon. 
     
     
         16 . The method of  claim 14 , wherein the ligament is an anterior cruciate ligament, lateral collateral ligament, posterior cruciate ligament, medial collateral ligament, cranial cruciate ligament, caudal cruciate ligament, cricothyroid ligament, periodontal ligament, suspensory ligament of the lens, anterior sacroiliac ligament, posterior sacroiliac ligament, sacrotuberous ligament, sacrospinous ligament, inferior pubic ligament, superior pubic ligament, suspensory ligament, palmar radiocarpal ligament, dorsal radiocarpal ligament, ulnar collateral ligament, or radial collateral ligament. 
     
     
         17 . The method of  claim 13 , wherein the soft tissue damage or injury is tendon or ligament rupture, severance, tearing, delamination, strain, or deformation. 
     
     
         18 . A kit comprising the biological fluid concentration device of  claim 1 , and one or more of an injection kit, a needle, a syringe, a buffer, a connector, tubing, a luer lock, a top vented cap, a bottom vented cap, a top non-vented cap, a bottom non-vented cep, a top plug, and a bottom plug.

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